BEUDAMED
    FDA Registration Active 🇨🇳 China

    Smart Technology Co., Ltd.

    Reg #: 3012416077 · FEI: 3012416077 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    9
    Establishment Types
    3
    Classifications
    8

    Registration Details

    Registration Name
    Smart Technology Co., Ltd.
    Registration Number
    3012416077
    FEI Number
    3012416077
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 422 Hai Tian Avenue, Gaoming District
    City
    Foshan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K202009

    Owner / Operator

    Firm Name
    SMART TECHNOLOGY CO LTD
    Operator Number
    10051751
    Address
    No. 422 Hai Tian Avenue, Gaoming District
    City
    Foshan
    State
    Guangdong
    Postal Code
    -
    Country
    CN
    Correspondent
    Mag M Mei

    US Agent

    Business Name
    SMARTEK INC
    Contact Name
    Mag Mei
    Address
    5534 Saint Joe Road,
    City
    Fort Wayne
    State
    IN
    ZIP
    46835
    Country
    US
    Email
    [email protected]
    Phone
    812 5528486

    Products

    Device Name Product Code
    Syringe, Ent KCP
    Continuous Measurement Thermometer FLL
    Syringe, Irrigating (Non Dental) KYZ
    Dispenser, Liquid Medication KYX
    Toothbrush, Manual EFW
    Humidifier, Non-Direct Patient Interface (Home-Use) KFZ
    Pad, Alcohol, Device Disinfectant LKB
    Ring, Teething, Non-Fluid Filled MEF

    Proprietary Names

    KCP/SYRINGE, ENT Probe Cover KYZ/ SYRINGE, IRRIGATING (NON DENTAL) KYX/ DISPENSER, LIQUID MEDICATION Digital Thermometer (DT100, TH093, TH111, TH074, TH112, TH114) EFW/TOOTHBRUSH, MANUAL FLL/Continuous Measurement Thermometer LKB/Pad, alcohol, device disinfectant MEF/RING, TEETHING, NON-FLUID FILLED

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device